drugset / Trial / NCT03494387

VitamIn and oXygen Interventions and Cardiovascular Events

NCT03494387 ↗

Phase 4 Completed 600 enrolled University Hospital Bispebjerg and Frederiksberg
RandomizedFactorialDouble-blindPrevention

Summary

This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.

Timeline

Start
2018-04-06
Primary completion
2020-03-01
Completion
2020-03-24

Outcome

Missed primary endpoint

paper HR 1.46 (95% CI, 0.79-2.70), p = 0.23. PMID 41055553 ↗

paper Antioxidants had a HR of 0.98 (95% CI, 0.54-1.80), p = 0.96 for all-cause mortality vs. placebo. PMID 41055553 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 100 mg/kg Intravenous
Subject Oxygen Other / unclassified — —
Subject Vitamin C Other / unclassified 3 g Intravenous

Indications

No indication recorded.